Established name required once per detailed-information column

AI-verifiedblockerFDA guidance · non-bindingCheckable — presence or a literal match settles it

Rule

If a column of running text with detailed composition, prescribing, side-effect, or contraindication information uses the proprietary name (without it being featured above or below the column), the established name must appear at least once in that column.

Check

For columns containing detailed composition/prescribing/side-effect/contraindication text, confirm the established name appears at least once in that column when the proprietary name is used there and not featured above or below it.

Where this comes from

21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.D · page 7. The highlighted words are quoted exactly; a script confirms they appear in the source before the rule can be published.

… name or designation each time it is featured in the advertisement [or on the label or in the labeling] for the drug . . . . On any page of an advertisement [or any label or page of labeling] in which the proprietary name or designation is not featured but is used in the running text, the established name shall be used at least once in the running text in association with such proprietary name or designation . . . . If any advertisement [or any labeling] includes a column with running text containing detailed information as to composition, prescribing, side effects, or contraindications and the proprietary name or designation is used in such column but is not featured above or below the column, the established name shall be used at least once in such column of running text in association with such proprietary name or designation . . . . (Emphasis added) 1. Traditional Print Promotional Labeling and Advertisements For traditional print promotional labeling and advertisements, the established name is required to accompany the proprietary name when the proprietary name is featured (e.g., headlines, taglines, logos, graphs, or pictures). Although the regulations state that the established name “shall Contains Nonbinding …

Open the original at page 7 on fda.gov ↗Read our full copy →

Document: FDA guidance: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling (final)
Version: as retrieved — the publisher does not version this document; the fingerprint below identifies the exact file
Retrieved: 2026-09-21 from www.fda.gov
Fingerprint: f6f78606542ef91596ef21f6…

FDA guidance describes the agency's current thinking. It is not binding law, and this rule is a recommendation, not an obligation.

Applies when

Naturepromotional

How this rule was checked

Citation proven by script and passed an independent verifier running on a different model. Not yet confirmed by a human.

Drafted
claude-code:sonnet · 2026-09-21
Independent verification — pass
claude-code:opus · 2026-09-21
Reviewer's reasons
- The quote is the regulatory text of 21 CFR 201.10(g)(1)/202.1(b)(1) as reproduced in Section II.D of the guidance, and it says in terms that where a column of running text carries detailed composition/prescribing/side-effect/contraindication information and the proprietary name is used in the column but not featured above or below it, 'the established name shall be used at least once in such column'. The rule statement tracks that sentence clause for clause, including the 'not featured above or below the column' condition.
- Not overstated: the mandatory phrasing ('must appear at least once in that column') comes from the regulation's own 'shall', not from the guidance's recommendations. The rule does not extend the requirement beyond columns or beyond columns with the listed detailed content.
- Atomic: a single checkable obligation — one appearance of the established name inside the qualifying column.
- Determinism 'deterministic' is defensible: once the column is identified, whether the established name appears in it at least once is settled by presence/absence, not by impression.
- Severity 'blocker' is defensible for a regulatory disclosure requirement about product identification.
- Locator is right: it cites both the CFR provisions and Section II.D where the text is reproduced.
- Observation, not a required change: because the operative text here is regulation rather than FDA recommendation, an 'authority' of binding would also be defensible; tagging it 'guidance' (the authority of the source document) understates rather than overclaims, so it is not a false-assurance error.

Nearby rules

US-NAME-029